The top vaccine official at the Food and Drug Administration, Dr Vinay Prasad, is once again leaving the agency – the second time in less than a year that he’s departed after decisions involving the review of vaccinations and specialty drugs for rare diseases.
FDA commissioner Marty Makary announced the news to FDA staff in an email late Friday, saying Prasad would depart at the end of April. Makary said Prasad would return to his academic job at the University of California, San Francisco.
“He got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month,” Makary said in a post on X. “We will name a successor before his departure.”
Prasad’s latest ouster follows a string of high-profile controversies involving the FDA’s review of vaccines, gene therapies and biotech drugs in which companies have criticized the agency for reversing itself, in some cases calling for new trials of products previously greenlighted by regulators.
In July, Prasad was briefly forced from his job after running afoul of biotech executives, patient groups and conservative allies of Donald Trump. Laura Loomer, the far-right influencer, led the charge against Prasad, taking issue with his past statements about Trump and his praise for progressive senator Bernie Sanders.
He was reinstated less than two weeks later with the backing of health secretary Robert F Kennedy Jr and Makary.
A longtime academic and critic of the FDA’s standards for drug reviews, Prasad has taken a seemingly contradictory approach to regulation since arriving at the FDA last May. On repeated occasions, Prasad has joined Makary in announcing steps to make FDA drug reviews faster and easier for companies. But he also has imposed new warnings and study requirements for some biotech drugs and vaccines, particularly Covid shots that have long been a target for Kennedy, a longtime anti-vaccine activist before joining the Trump administration.
Last month, Prasad refused to consider Moderna’s application for a new, potentially more effective flu shot based on messenger RNA (mRNA) technology, prompting backlash from medical experts who described the decision as part of a broader “anti-vaccine agenda”.
The vaccine application was rejected because it did not have an “adequate and well controlled” trial, with the control group lacking “the best-available standard of care in the United States at the time of the study”, according to a letter by Prasad.
The FDA quickly changed course after it faced pressure from the White House.
Prasad took over the position after Dr Peter Marks resigned in March after having been given the choice to resign or be fired by a Health and Human Services (HHS) department official. Marks was seen as a guardrail against what would become the politicization of the FDA, having served a key role in Operation Warp Speed, the initiative that developed, manufactured and helped distribute the Covid-19 vaccines.
Before taking on the role at the FDA, Prasad was a professor of epidemiology and biostatistics and medicine at UCSF. He has also had stints at the National Cancer Institute and the National Institutes of Health.
